Rationale and design of ApoA-I Event Reducing in Ischemic Syndromes II (AEGIS-II): A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy and safety of CSL112 in subjects after acute myocardial infarction

• Published in: The American heart journal Vol. 231; pp. 121 - 127
• Main Authors: Gibson, C. Michael, Kastelein, John J.P., Phillips, Adam T., Aylward, Philip E., Yee, Megan K., Tendera, Michal, Nicholls, Stephen J., Pocock, Stuart, Goodman, Shaun G., Alexander, John H., Lincoff, A. Michael, Bode, Christoph, Duffy, Danielle, Heise, Mark, Berman, Gail, Mears, Sojaita Jenny, Tricoci, Pierluigi, Deckelbaum, Lawrence I., Steg, P. Gabriel, Ridker, Paul, Mehran, Roxana
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.01.2021; Elsevier Limited
• Subjects: Acute coronary syndromes; Aged; Apolipoprotein A; Apolipoprotein A-I; Arteriosclerosis; Atherosclerosis; Blood plasma; Brain Ischemia - prevention & control; Cardiac catheterization; Cardiovascular disease; Cerebral infarction; Cholesterol; Cholesterol - metabolism; Clinical Trials, Phase III as Topic; Coronary artery; Coronary artery disease; Coronary Artery Disease - metabolism; Coronary vessels; Creatinine; Diabetes mellitus; Diabetes Mellitus - drug therapy; Double-Blind Method; Double-blind studies; Drug Administration Schedule; Drug therapy; Efflux; Heart attacks; Heart diseases; Heart failure; Hospitalization - statistics & numerical data; Humans; Intravenous administration; Intubation; Ischemia; Ischemia - prevention & control; Kidney diseases; Lipoproteins, HDL - administration & dosage; Lipoproteins, HDL - adverse effects; Lipoproteins, HDL - therapeutic use; Liver - metabolism; Mortality; Multicenter Studies as Topic; Myocardial infarction; Myocardial Infarction - prevention & control; Myocardial Infarction - therapy; Myocardial Ischemia - prevention & control; Peripheral Vascular Diseases - prevention & control; Placebos - therapeutic use; Plaque, Atherosclerotic - metabolism; Randomized Controlled Trials as Topic; Safety; Stroke - prevention & control; Time Factors; Vascular diseases

Acute myocardial infarction (MI) patients remain at high risk for recurrent events. Cholesterol efflux, mediated by apolipoprotein A-I, removes excess cholesterol from atherosclerotic plaque and transports it to the liver for excretion. Impaired cholesterol efflux is associated with higher cardiovas...